Abstract
Synopsis
Here is a brief excerpt taken from a decision recently issued by a UK patent court that exemplifies the more-relaxed standard of patent eligibility being applied in Europe as compared to the United States. The accused infringer argued that claim 1 of UK patent EP (UK) 0,994,963 is invalid because it is a “mere discovery and is not technical”—essentially the European equivalent of an accusation of patent ineligibility under U.S. law. The UK court rejected this argument, finding that the claim is “not directed to information about the natural world, but rather to a practical process, namely a ‘detection method’ which uses information about the natural world.” The court noted that the claim is directed towards the detection of fetal DNA in a sample of plasma or serum, and that such samples do not exist in the natural world but rather must be created artificially. Nor does the method of detection exist in the natural world. Notably, the accused infringer did not even attempt to challenge the patent eligibility of dependent claim 8, directed towards use of the method of claim 1 to determine the sex of the fetus, and this claim was found to be infringed by the accused infringer's non-invasive prenatal test. The fate of these claims was very different in the United States, where in Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1381 (Fed. Cir. 2015), the Court of Appeals of the Federal Circuit invalidated essentially the same claims for lack of patent eligibility. Compare claims 1 and 12 from U.S. patent number 6,258,540 (found to be patent ineligible) with claims 1 and 8 from EP (UK) 0,994,963 (patent eligible and infringed, respectively).
Ariosa v. Sequenom has been discussed at length in previous issues of Biotechnology Law Report. See, for example, Christopher M. Holman, The Biotechnology Industry Organization (BIO) and Pharmaceutical Research and Manufacturers of America (PhRMA) Seek En Banc Review of Ariosa Diagnostics v. Sequenom, 34
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Discovery As Such
Legal principles
184. Pursuant to section 130(7), section 1(2) of the Patents Act 1977 is framed so as to have, as nearly as practicable, the same effect as the corresponding provisions of Articles 52(2) and (3) of the European Patent Convention. Section 1(2)(a) and Articles 52(2)(a) and (3) declare that discoveries “as such” are not inventions. Lord Hoffmann explained in Kirin-Amgen at [77] that: “An invention is a practical product or process, not information about the natural world.”
185. It is necessary to distinguish substance from form, as emphasised by Lewison J (as he then was) in Tate & Lyle Technology Ltd v Roquette Freres [2010] FSR 1 at [75]: “The claim is not saved from unpatentability simply by the addition of the phrase “the use of”. What matters is the substance of the claim rather than its form.”
186. A four-part structured approach to objections of excluded subject matter was set out by the Court of Appeal in Aerotel Ltd v Telco Holdings Ltd; Macrossan's Application [2007] RPC 7, and further explained by the Court of Appeal in Symbian Ltd v Comptroller General of Patents [2009] RPC 1. This requires the Court to:
(i) properly construe the claim; (ii) identify the actual contribution; (iii) ask whether the identified contribution falls solely within the excluded subject matter; and (iv) check whether the actual or alleged contribution is actually technical in nature.
187. TDL/Ariosa submitted that, on Illumina's construction, claim 1 [of EP (UK) 0,994,963] is in substance a claim to any method involving the discovery that foetal DNA that is paternally inherited and not possessed by the mother is detectable in maternal serum/plasma. There are no technical limits imposed on the method of detection. Nor, on Illumina's case, is there any requirement that the method of claim 1 results or enables any meaningful technical effect. It submitted that the claim, in substance, claims the discovery disclosed at page 2 lines 4 to 5 of the Priority Document, dressed up as a method claim. The contribution is simply the discovery that certain foetal nucleic acids that are paternally inherited and not possessed by the mother are detectable in maternal serum or plasma samples. That contribution is a mere discovery and is not technical.
188. TDL/Ariosa accepted that claim 8 [of EP (UK) 0,994,963] does not relate to excluded subject matter, and I have accepted its case that claims 1, 2, 5 and 7 are invalid. Therefore, it is unnecessary for me to resolve this issue. Nonetheless, in case I am wrong, I shall briefly express my conclusions.
189. I do not accept that, properly construed, claim 1 is a claim to a discovery as such. The claims are not directed to information about the natural world, but rather to a practical process, namely a “detection method” which uses information about the natural world. Claim 1 is directed to the detection of foetal DNA in a sample of plasma or serum. Such samples do not exist in the natural world and must be artificially created. The claimed method of detection is also an artificial process which does not exist in the natural world. The claim is to a practical process of implementing a discovery, for practical applications. The actual contribution, as a matter of substance, does not fall solely within the excluded subject matter and is technical in nature.